Chicago, Illinois, United States, October 20, 2026
Prenosis, a biology-based technology company focused on precision medicine, and Carle Health have announced major milestones in their clinical collaboration, including the live deployment of Sepsis ImmunoScore® in clinical workflows and the enrollment of the first patients in the OBSERVE-ARDS clinical study. The announcement marks progress in applying artificial intelligence (AI) and biological data to support the assessment of critically ill patients. Sepsis ImmunoScore is integrated into Carle Health’s electronic health record (EHR) system and analyzes 22 parameters, including vital signs, laboratory results and immune biomarkers, to help clinicians identify patients who may have or develop sepsis within 24 hours. In parallel, Carle Health has become the first active site in Prenosis’ observational study of acute respiratory distress syndrome (ARDS). The initiatives build on a long-standing partnership between the organizations, which has involved algorithm development, clinical evaluation and implementation research. Together, the milestones support Prenosis’ broader effort to develop precision medicine tools that connect patient-specific biological information with clinical decision-making and research.
Sepsis ImmunoScore Enters Clinical Workflow at Carle Health
Sepsis ImmunoScore is designed to support the early identification of patients at risk of sepsis, a serious condition in which the body’s response to infection can lead to organ dysfunction and life-threatening complications. Recognizing sepsis promptly can be challenging because symptoms overlap with other illnesses and patients may deteriorate rapidly. Integrated directly into Carle Health’s EHR system, the AI-powered diagnostic tool evaluates 22 patient parameters to generate information that clinicians can consider alongside their own assessment. The system is intended to complement healthcare professionals’ judgment rather than replace clinical decision-making. Prenosis and Carle Health have collaborated since the early stages of the technology’s development, with Carle clinicians and researchers contributing data and expertise to help build the underlying algorithm. The health system also participated in a silent-implementation study that examined the tool’s influence on provider judgment before its introduction into live clinical practice. Sepsis ImmunoScore received FDA De Novo authorization in April 2024, according to Prenosis. Its clinical deployment at Carle Health now provides an opportunity to evaluate the technology within routine workflows and further assess its clinical utility and performance.
OBSERVE-ARDS Study Enrolls Its First Patients
Carle Health has also become the first active clinical site and enrolled the first participants in OBSERVE-ARDS, Prenosis’ observational study focused on acute respiratory distress syndrome. ARDS is a severe form of respiratory failure characterized by inflammation, fluid accumulation in the lungs and impaired oxygen exchange. The condition can arise from several underlying illnesses, including severe infections, and outcomes vary considerably among patients. The OBSERVE-ARDS study is intended to support the collection of clinical information and biological samples that may help researchers characterize different patient profiles and investigate approaches to predicting treatment response. Prenosis’ Immunix® platform is integrated with Carle Health’s EHR system to support patient screening and recruitment, identification of suitable remnant samples and collection of study data. This existing integration may also reduce the time required to activate the site for subsequent research compared with establishing a new, non-integrated location. Carle Health plans to participate in Prenosis’ Steroid Therapy Optimization for Prevention of Acute Respiratory Distress Syndrome (STOP ARDS) study as well. Both studies are part of the Biomedical Advanced Research and Development Authority’s (BARDA) Type to Treat Program, which supports precision medicine platforms designed to guide the use of therapeutic medical countermeasures.
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Precision Medicine Network Supports Future Research
The collaboration is part of Prenosis’ effort to establish a clinical research network involving up to 40 academic medical centers. By connecting participating health systems through its Immunix platform, the company aims to facilitate the identification of patients with specific biological and physiological profiles and support enrollment into relevant clinical studies. This infrastructure could help researchers investigate why patients with apparently similar conditions respond differently to treatments and develop more individualized approaches to acute illness. Carle Health’s early involvement, from contributing to the underlying research to implementing Sepsis ImmunoScore and activating OBSERVE-ARDS, illustrates how long-term partnerships between healthcare providers and technology developers can support clinical translation. The work is partly supported by federal funding through the U.S. Department of Health and Human Services and BARDA. The current milestones demonstrate clinical deployment and study enrollment, not proof that the tools improve patient outcomes. Further research will be needed to establish the diagnostic performance, clinical impact and potential role of these technologies across additional healthcare settings. Nevertheless, integrating AI-based diagnostic tools with clinical research infrastructure represents an important step toward evaluating precision medicine approaches for sepsis and ARDS.
Source: Prenosis press release
